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目的:建立HPLC法同时测定复方柳安咖注射液中水杨酸钠、安替比林、咖啡因3组分的含量。方法:色谱柱为Dia- monsil(TM)C_(18)(250 mm×4.6 mm,5μm),流动相为0.05 mol·L~(-1)磷酸二氢钾溶液(含0.12%三乙胺,用氢氧化钠试液调节pH 7.0±0.05)-甲醇(69∶31)。检测波长为273 nm;流速1.0 ml·min~(-1);柱温:30℃。结果:水杨酸钠在14.18～127.60μg·ml~(-1)范围内线性关系好(r=0.999 8),平均回收率为99.17%,RSD=0.56%(n=6);安替比林在4.00～36.04μg·ml~(-1)范围内线性关系好(r=0.999 9),平均回收率为101.71%,RSD=0.41%(n=6);咖啡因在2.16～19.48μg·ml~(-1)范围内线性关系好(r =0.999 8),平均回收率为101.40%,RSD=0.93%(n=6)。结论:本方法简便,快速,准确,重现性好,可用于复方柳安咖注射液的质量控制。
Objective: To establish an HPLC method for the simultaneous determination of the three components of sodium salicylate, antipyrine and caffeine in compound Liu’ancao injection. METHODS: The mobile phase consisted of 0.05 mol·L -1 potassium dihydrogen phosphate solution (containing 0.12% triethylamine, PH 7.0 ± 0.05) -methanol (69:31) was adjusted with sodium hydroxide solution. The detection wavelength was 273 nm. The flow rate was 1.0 ml · min -1. The column temperature was 30 ℃. Results: The linearity of sodium salicylate in the range of 14.18 ~ 127.60μg · ml ~ (-1) was good (r = 0.999 8), the average recovery was 99.17% and the RSD was 0.56% (n = 6) The linear range was 4.00 ~ 36.04 μg · ml -1 (r = 0.999 9), the average recovery was 101.71%, RSD was 0.41% (n = 6), and the range of 2.16 ~ 19.48 μg · The linear relationship was good (r = 0.999 8) with an average recovery of 101.40% and RSD 0.93% (n = 6). Conclusion: The method is simple, rapid, accurate and reproducible. It can be used for the quality control of compound Liuancao injection.